FDA WARNING_LETTER - Beta Bionics, Inc - June 26, 2025

FDA WARNING_LETTER for Beta Bionics, Inc on June 26, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Beta Bionics, Inc on June 26, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 803.3(w)(3)

21 U.S.C. 352(t)(2)

FD&C Act 501(h)

21 CFR 803.3(o)(2)(i)

21 CFR 806.1(b)

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 806.10(f)

21 CFR 803.50(a)

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Record Information

Company

Beta Bionics, Inc

Inspection Date

June 26, 2025

Product Type

devices

Office

Center for Devices and Radiological Health

People

ID: c6b1f368-96fc-4e24-ac7a-648fd522cbdb

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